N/A NL850500VRecalls & reported problems
Integra Lifesciences Corporation · Ventricular Drainage System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780211082), received between Jun 14, 2024 and Jun 14, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Complete Blockage” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Complete Blockage1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2024Complete Blockage; Complete Blockage
A FACILITY REPORTED THE FOLLOWING: "PATIENT WITH INTEGRA DVE SYSTEM INSTALLED ON 9 MAY IN THE OR. PATIENT WITH INTRACRANIAL HYPERTENSION, LABILE, INCREASED THERAPY TO CONTROL HIGH INTRACRANIAL PRESSURE. EVD LOWERED FROM +15 TO 0CM H20. ANOMALY IN THE DRAINAGE SYSTEM. WE HAD TO CLAMP THE EVD, OPEN THE VALVE TO PURGE THE BURETTE, THEN CLOSE IT, AND UNCLAMP THE EVD. WHEN WE DID THIS, JUST AFTER DECLAMPING, THE BURETTE FILLED UP CONSIDERABLY, SUGGESTING THAT THE CSF WAS POORLY DRAINED. NO SOAKED PAPER FILTER, AS ON THE CODMANN AT THE REQUEST OF THE PHYSICIAN, WE CHANGED THE SYSTEM FOR A CODMANN. SINCE THEN, THE EVD HAS BEEN GIVING CONTINUOUS AND MUCH MORE STABLE INTRACRANIAL PRESSURE. CONSEQUENCES DIFFICULT TO ASSESS, AS HIGH INTRACRANIAL PRESSURE LEADS TO NEUROLOGICAL SEQUELAE THAT CANNOT BE ASSESSED IN THE ACUTE PHASE OF TREATMENT. THE PATIENT HAS LOST THE CHANCE OF WAKING UP DUE TO PERSISTENT AND DIFFICULT-TO-CONTROL HIGH INTRACRANIAL PRESSURE, BUT THIS IS IMPOSSIBLE TO ASSESS. PATIENT WHO HAS UNDERGONE INCREASED THERAPY TO CONTROL HIGH INTRACRANIAL PRESSURE (EXTERNAL COOLING, THIOPENTAL, BRAIN SCAN TO DETERMINE PERSISTENCE OF HYDROCEPHALUS), STILL SEDATED AND CURARIZED. THE PART OF
Patient problems: Insufficient Information
MAUDE report 19539034 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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